HypercholesterolemiaPhase 3V-MonoNCT05763875
Efficacy and Safety of Inclisiran as Monotherapy in Patients With Primary Hypercholesterolemia Not Receiving Lipid-lowering Therapy.
A Phase 3 study testing Inclisiran and Ezetimibe in people with Hypercholesterolemia, run by Novartis Pharmaceuticals at 42 sites in 5 countries.
Trial summary
CKJX839D12304 was a research study to determine if the study treatment, called inclisiran, in comparison to placebo and ezetimibe effectively reduces Low-Density Lipoprotein Cholesterol (LDL-C) as measured by percentage change from baseline to Day 150. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- Inclisiran and Ezetimibe
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 350 participants
- Where
- 42 sitesin 5 countries
- Study dates
- 15 Mar 2023to 20 Jun 2024
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- informed consent signed prior to participation in study
- fasting LDL-C of >= 100 mg/dL but < 190 mg/dL
- fasting triglycerides <= 400 mg/dL
- 10-year ASCVD risk score < 7.5%
- not on any lipid-lowering therapy within 90 days of screening
Who cannot join
- history of ASCVD
- diabetes mellitus or fasting plasma glucose of >= 7.0 mmol/L or HbA1c >= 6.5%
- secondary hypercholesterolemia, e.g. hypothyroidism (TSH above upper limit of normal)
Trial locations and contacts
42 sites in 5 countries.
42 sites in 5 countries
United States22 sites
Parkway Medical Center
Birmingham, Alabama, 35215
Grace Research LLC
Bossier City, Louisiana, 71111
Hillcrest Medical Research
DeLand, Florida, 32720
SEC Clinical Research
Dothan, Alabama, 36305
Conrad Clinical Research
Edmond, Oklahoma, 73013
Lillestol Research LLC
Fargo, North Dakota, 58103
WellNow Urgent Care and Research
Huber Heights, Ohio, 45424
ClinCloud
Maitland, Florida, 32751
Alma Clinical Research Inc
Miami, Florida, 33165
Inpatient Research Clinical LLC
Miami Lakes, Florida, 33014
Monroe Biomedical Research
Monroe, North Carolina, 28112
Koch Family Medicine
Morton, Illinois, 61550
Compass Point Research
Nashville, Tennessee, 37203
Harmony Clinical Research
North Miami Beach, Florida, 33162
Fam Medical Specialists Of Fl Plc
Plant City, Florida, 33563
Dominion Medical Associates
Richmond, Virginia, 23219
Grace Research Llc
Shreveport, Louisiana, 71101
Mt Olympus Medical Research
Sugar Land, Texas, 77479
Prime Global Research Inc
The Bronx, New York, 10456
Spaulding Clinical Research
West Bend, Wisconsin, 53095
Southern Clin Research Clinic
Zachary, Louisiana, 70791
Cozy Research LLC
Zephyrhills, Florida, 33541
Germany9 sites
Novartis Investigative Site
Berlin, 10787
Novartis Investigative Site
Bochum, 44789
Novartis Investigative Site
Gladbeck, 45968
Novartis Investigative Site
Hamburg, 22607
Novartis Investigative Site
Hanover, Lower Saxony, 30449
Novartis Investigative Site
Jerichow, Saxony-Anhalt, 39319
Novartis Investigative Site
Löhne, North Rhine-Westphalia, 32584
Novartis Investigative Site
Munich, Bavaria, 80809
Novartis Investigative Site
Papenburg, 26871
Mexico5 sites
Novartis Investigative Site
Culiacan Sinaloa, 80230
Novartis Investigative Site
Mérida, Yucatán, 97070
Novartis Investigative Site
Monterrey, Nuevo León, 64060
Novartis Investigative Site
Monterrey, Nuevo León, 64440
Novartis Investigative Site
Querétaro, 76000
Colombia4 sites
Novartis Investigative Site
Barranquilla, Atlántico, 080012
Novartis Investigative Site
Floridablanca, Santander Department, 57-7
Novartis Investigative Site
Manizales, 170008
Novartis Investigative Site
San Gil, 684031
Hungary2 sites
Novartis Investigative Site
Budapest, 1083
Novartis Investigative Site
Pécs, 7623
About this study
Official title: A Double-blind, Randomized, Placebo- and Active-Comparator Controlled Study to Evaluate the Efficacy of Inclisiran as Monotherapy in Patients With Primary Hypercholesterolemia Not Receiving Lipid-Lowering Therapy (VictORION-Mono)
CKJX839D12304 was a research study to determine if the study treatment, called inclisiran, in comparison to placebo and ezetimibe effectively reduces Low-Density Lipoprotein Cholesterol (LDL-C) as measured by percentage change from baseline to Day 150. This study was conducted in eligible participants with primary hypercholesterolemia not receiving any lipid-lowering therapy (LLT), with a 10-year Atherosclerotic Cardiovascular Disease (ASCVD) risk of less than 7.5%.
Read the detailed description
This study was a randomized, double-blind, placebo- and active comparator-controlled, multicenter study in 350 adult participants with primary hypercholesterolemia not receiving any LLT with a 10-year ASCVD risk score of less than 7.5%. This study evaluated the efficacy and safety of inclisiran sodium 300 mg, administered as a monotherapy in comparison to ezetimibe and placebo.
The study consisted of:
- a screening period of up to 14 days;
- a double-blind treatment period of 150+/- 5 days during which participants were randomly assigned to either the inclisiran arm, the ezetimibe arm or the placebo arm in a 2:1:1 ratio; and
- a safety follow-up / End of Study visit conducted 30+5 days after the Day 150 visit.
The overall study duration was approximately 190 days.
- Conditions
- Hypercholesterolemia
- Being tested
- Inclisiran, Ezetimibe, Matching Placebo for Inclisiran, Matching Placebo for Ezetimibe
- Keywords
- inclisiran, ezetimibe, LDL-C, monotherapy, primary hypercholesterolemia
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InclisiranDrug
Also called KJX839
284 mg (equivalent to 300 mg inclisiran sodium) subcutaneous injection given on Day 1 and Day 90
EzetimibeDrug
Also called Sandoz ezetimibe
10 mg over-encapsulated tablet taken once a day from Day 1 through Day 149
Matching Placebo for InclisiranDrug
Also called Placebo s.c.
0mg placebo injection solution for subcutaneous injection on Day 1 and Day 90
Matching Placebo for EzetimibeDrug
Also called Placebo p.o.
0mg over-encapsulated placebo tablet taken once a day from Day 1 through Day 149
| Study group | Role | What they receive |
|---|---|---|
| Inclisiran | Experimental | Inclisiran s.c and Placebo p.o Receives: Drug: Inclisiran; Drug: Matching Placebo for Ezetimibe |
| Ezetimibe | Active comparator | Placebo s.c. and Ezetimibe p.o. Receives: Drug: Ezetimibe; Drug: Matching Placebo for Inclisiran |
| Placebo | Placebo comparator | Placebo s.c. and Placebo p.o. Receives: Drug: Matching Placebo for Inclisiran; Drug: Matching Placebo for Ezetimibe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 150
Percentage change in LDL-C from Baseline (day 1) to Day 150, Inclisiran arm versus Ezetimibe and placebo.
There were two estimands of interest in comparing efficacy of inclisiran as monotherapy against that of placebo or ezetimibe that differ on the treatment of interest used for each and the management of intercurrent events as follows:
- Monotherapy Estimand: Inclisiran as monotherapy compared to the use of comparator. This estimand uses a hypothetical strategy where participants who permanently discontinued treatment, died or used other LLTs were handled in a hypothetical scenario of what would have happened if the intercurrent event did not happen.
- Treatment-policy Estimand: Inclisiran as monotherapy compared to the use of comparator with or without other lipid lowering therapies (LLTs) added. This estimand ignored the use of other LLTs and treatment discontinuation. Deaths (if any) were handled as an unfavorable outcome using a composite variable strategy.
Measured: Baseline, Day 150
Secondary outcomes (8)
Absolute Change in LDL-C From Baseline to Day 150
Absolute change in LDL-C from Baseline (Day 1) to Day 150, Inclisiran arm versus Ezetimibe and placebo.
There were two estimands of interest in comparing efficacy of inclisiran as monotherapy against that of placebo or ezetimibe that differ on the treatment of interest used for each and the management of intercurrent events as follows:
- Monotherapy Estimand: Inclisiran as monotherapy compared to the use of comparator. This estimand uses a hypothetical strategy where participants who permanently discontinued treatment, died or used other LLTs were handled in a hypothetical scenario of what would have happened if the intercurrent event did not happen.
- Treatment-policy Estimand: Inclisiran as monotherapy compared to the use of comparator with or without other lipid lowering therapies (LLTs) added. This estimand ignored the use of other LLTs and treatment discontinuation. Deaths (if any) were handled as an unfavorable outcome using a composite variable strategy.
Measured: Baseline, Day 150
Percentage Change in Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) From Baseline to Day 150
Percentage change in PCSK9 from Baseline (Day 1) to Day 150 , Inclisiran arm versus Ezetimibe and placebo.
There were two estimands of interest in comparing efficacy of inclisiran as monotherapy against that of placebo or ezetimibe that differ on the treatment of interest used for each and the management of intercurrent events as follows:
- Monotherapy Estimand: Inclisiran as monotherapy compared to the use of comparator. This estimand uses a hypothetical strategy where participants who permanently discontinued treatment, died or used other LLTs were handled in a hypothetical scenario of what would have happened if the intercurrent event did not happen.
- Treatment-policy Estimand: Inclisiran as monotherapy compared to the use of comparator with or without other lipid lowering therapies (LLTs) added. This estimand ignored the use of other LLTs and treatment discontinuation. Deaths (if any) were handled as an unfavorable outcome using a composite variable strategy.
Measured: Baseline, Day 150
Percentage Change in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Day 150
Percentage change in non-HDL-C from Baseline (Day 1) to Day 150, Inclisiran arm versus Ezetimibe and placebo.
There were two estimands of interest in comparing efficacy of inclisiran as monotherapy against that of placebo or ezetimibe that differ on the treatment of interest used for each and the management of intercurrent events as follows:
- Monotherapy Estimand: Inclisiran as monotherapy compared to the use of comparator. This estimand uses a hypothetical strategy where participants who permanently discontinued treatment, died or used other LLTs were handled in a hypothetical scenario of what would have happened if the intercurrent event did not happen.
- Treatment-policy Estimand: Inclisiran as monotherapy compared to the use of comparator with or without other lipid lowering therapies (LLTs) added. This estimand ignored the use of other LLTs and treatment discontinuation. Deaths (if any) were handled as an unfavorable outcome using a composite variable strategy.
Measured: Baseline, Day 150
Percentage Change in Total Cholesterol (TC)/HDL-C Ratio From Baseline to Day 150
Percentage change in total cholesterol/HDL-C ratio from Baseline (Day1) to Day 150, Inclisiran arm versus Ezetimibe and placebo.
There were two estimands of interest in comparing efficacy of inclisiran as monotherapy against that of placebo or ezetimibe that differ on the treatment of interest used for each and the management of intercurrent events as follows:
- Monotherapy Estimand: Inclisiran as monotherapy compared to the use of comparator. This estimand uses a hypothetical strategy where participants who permanently discontinued treatment, died or used other LLTs were handled in a hypothetical scenario of what would have happened if the intercurrent event did not happen.
- Treatment-policy Estimand: Inclisiran as monotherapy compared to the use of comparator with or without other lipid lowering therapies (LLTs) added. This estimand ignored the use of other LLTs and treatment discontinuation. Deaths (if any) were handled as an unfavorable outcome using a composite variable strate
Measured: Baseline, Day 150
Percentage Change in Apolipoprotein B (Apo B) From Baseline to Day 150
Percentage change in Apo B from Baseline (Day 1) to Day 150, Inclisiran arm versus Ezetimibe and placebo.
There were two estimands of interest in comparing efficacy of inclisiran as monotherapy against that of placebo or ezetimibe that differ on the treatment of interest used for each and the management of intercurrent events as follows:
- Monotherapy Estimand: Inclisiran as monotherapy compared to the use of comparator. This estimand uses a hypothetical strategy where participants who permanently discontinued treatment, died or used other LLTs were handled in a hypothetical scenario of what would have happened if the intercurrent event did not happen.
- Treatment-policy Estimand: Inclisiran as monotherapy compared to the use of comparator with or without other lipid lowering therapies (LLTs) added. This estimand ignored the use of other LLTs and treatment discontinuation. Deaths (if any) were handled as an unfavorable outcome using a composite variable strategy.
Measured: Baseline, Day 150
Percentage Change in Apo B/Apo A-1 Ratio From Baseline to Day 150
Percentage change in Apo B/Apo A-1 ratio from baseline (Day 1) to Day 150, Inclisiran arm versus Ezetimibe and placebo.
There were two estimands of interest in comparing efficacy of inclisiran as monotherapy against that of placebo or ezetimibe that differ on the treatment of interest used for each and the management of intercurrent events as follows:
- Monotherapy Estimand: Inclisiran as monotherapy compared to the use of comparator. This estimand uses a hypothetical strategy where participants who permanently discontinued treatment, died or used other LLTs were handled in a hypothetical scenario of what would have happened if the intercurrent event did not happen.
- Treatment-policy Estimand: Inclisiran as monotherapy compared to the use of comparator with or without other lipid lowering therapies (LLTs) added. This estimand ignored the use of other LLTs and treatment discontinuation. Deaths (if any) were handled as an unfavorable outcome using a composite variable strategy.
Measured: Baseline, Day 150
Change in Lipoprotein (a) [Lp(a)] From Baseline to Day 150
Day 150 / Baseline ratio in Lp(a) in Inclisiran arm versus Ezetimibe and placebo.
There were two estimands of interest in comparing efficacy of inclisiran as monotherapy against that of placebo or ezetimibe that differ on the treatment of interest used for each and the management of intercurrent events as follows:
- Monotherapy Estimand: Inclisiran as monotherapy compared to the use of comparator. This estimand uses a hypothetical strategy where participants who permanently discontinued treatment, died or used other LLTs were handled in a hypothetical scenario of what would have happened if the intercurrent event did not happen.
- Treatment-policy Estimand: Inclisiran as monotherapy compared to the use of comparator with or without other lipid lowering therapies (LLTs) added. This estimand ignored the use of other LLTs and treatment discontinuation. Deaths (if any) were handled as an unfavorable outcome using a composite variable strategy.
Measured: Baseline, Day 150
Incidence of Treatment Emergent Adverse Events (TEAE) and Serious Adverse Events (SAE)
Incidence of TEAEs (regardless of seriousness) and SAEs by treatment group, including changes in laboratory results qualifying and reported as AEs.
Measured: From first dose of study treatment on Day 1 up to Day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2023
- Study start15 Mar 2023
- Primary completion20 Jun 2024
- Study completion20 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multi-center, randomized, double-blind, placebo- and active comparator-controlled, parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05763875
- Sponsor's protocol ID
- CKJX839D12304
- Acronym
- V-Mono
- Status last verified
- Oct 2025
- First submitted
- 28 Feb 2023
- Last updated
- 16 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Publications
Taub PR, Gutierrez A, Wewers D, Garcia Cantu E, Cao H, Deck C, Lesogor A, Ott D, Mena-Madrazo J, Zang X, Wright RS. Safety and Lipid-Lowering Efficacy of Inclisiran Monotherapy in Patients Without ASCVD: The VICTORION-Mono Randomized Clinical Trial. J Am Coll Cardiol. 2025 Jul 22;86(3):196-208. doi: 10.1016/j.jacc.2025.04.049. Epub 2025 May 5.
PubMed 40392667
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Placebo- and Active-Comparator Controlled Study to Evaluate the Efficacy of Inclisiran as Monotherapy in Patients With Primary Hypercholesterolemia Not Receiving Lipid-Lowering Therapy (VictORION-Mono)
- ClinicalTrials.gov ID
- NCT05763875
- Acronym / sponsor ID
- V-Mono / CKJX839D12304
- Conditions
- Hypercholesterolemia
- Keywords
- inclisiran, ezetimibe, LDL-C, monotherapy, primary hypercholesterolemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- 20 Jun 2024 (actual)
- Study completion
- 20 Jun 2024 (actual)
- First posted
- 10 Mar 2023 (actual)
- Results
- Posted 13 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
CKJX839D12304 was a research study to determine if the study treatment, called inclisiran, in comparison to placebo and ezetimibe effectively reduces Low-Density Lipoprotein Cholesterol (LDL-C) as measured by percentage change from baseline to Day 150. This study was conducted in eligible participants with primary hypercholesterolemia not receiving any lipid-lowering therapy (LLT), with a 10-year Atherosclerotic Cardiovascular Disease (ASCVD) risk of less than 7.5%.
Detailed description
This study was a randomized, double-blind, placebo- and active comparator-controlled, multicenter study in 350 adult participants with primary hypercholesterolemia not receiving any LLT with a 10-year ASCVD risk score of less than 7.5%. This study evaluated the efficacy and safety of inclisiran sodium 300 mg, administered as a monotherapy in comparison to ezetimibe and placebo.
The study consisted of:
- a screening period of up to 14 days;
- a double-blind treatment period of 150+/- 5 days during which participants were randomly assigned to either the inclisiran arm, the ezetimibe arm or the placebo arm in a 2:1:1 ratio; and
- a safety follow-up / End of Study visit conducted 30+5 days after the Day 150 visit.
The overall study duration was approximately 190 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- Multi-center, randomized, double-blind, placebo- and active comparator-controlled, parallel groups
| Arm | Type | Receives |
|---|---|---|
| Inclisiran | Experimental | Drug: Inclisiran, Drug: Matching Placebo for EzetimibeInclisiran s.c and Placebo p.o |
| Ezetimibe | Active comparator | Drug: Ezetimibe, Drug: Matching Placebo for InclisiranPlacebo s.c. and Ezetimibe p.o. |
| Placebo | Placebo comparator | Drug: Matching Placebo for Inclisiran, Drug: Matching Placebo for EzetimibePlacebo s.c. and Placebo p.o. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- informed consent signed prior to participation in study
- fasting LDL-C of >= 100 mg/dL but < 190 mg/dL
- fasting triglycerides <= 400 mg/dL
- 10-year ASCVD risk score < 7.5%
- not on any lipid-lowering therapy within 90 days of screening
Key exclusion criteria (3 listed)
- history of ASCVD
- diabetes mellitus or fasting plasma glucose of >= 7.0 mmol/L or HbA1c >= 6.5%
- secondary hypercholesterolemia, e.g. hypothyroidism (TSH above upper limit of normal)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InclisiranAlso: KJX839284 mg (equivalent to 300 mg inclisiran sodium) subcutaneous injection given on Day 1 and Day 90 | Drug | Inclisiran |
| EzetimibeAlso: Sandoz ezetimibe10 mg over-encapsulated tablet taken once a day from Day 1 through Day 149 | Drug | Ezetimibe |
| Matching Placebo for InclisiranAlso: Placebo s.c.0mg placebo injection solution for subcutaneous injection on Day 1 and Day 90 | Drug | Ezetimibe, Placebo |
| Matching Placebo for EzetimibeAlso: Placebo p.o.0mg over-encapsulated placebo tablet taken once a day from Day 1 through Day 149 | Drug | Inclisiran, Placebo |
Primary outcome
Percentage Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 150
Time frame: Baseline, Day 150
Percentage change in LDL-C from Baseline (day 1) to Day 150, Inclisiran arm versus Ezetimibe and placebo. There were two estimands of interest in comparing efficacy of inclisiran as monotherapy against that of placebo or ezetimibe that differ on the treatment of interest used for each and the management of intercurrent events as follows: * Monotherapy Estimand: Inclisiran as monotherapy compared to the use of comparator. This estimand uses a hypothetical strategy where participants who permanently discontinued treatment, died or used other LLTs were handled in a hypothetical scenario of what would have happened if the intercurrent event did not happen. * Treatment-policy Estimand: Inclisiran as monotherapy compared to the use of comparator with or without other lipid lowering therapies (LLTs) added. This estimand ignored the use of other LLTs and treatment discontinuation. Deaths (if any) were handled as an unfavorable outcome using a composite variable strategy.
8 secondary outcomes
Absolute Change in LDL-C From Baseline to Day 150
Time frame: Baseline, Day 150
Percentage Change in Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) From Baseline to Day 150
Time frame: Baseline, Day 150
Percentage Change in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) From Baseline to Day 150
Time frame: Baseline, Day 150
Percentage Change in Total Cholesterol (TC)/HDL-C Ratio From Baseline to Day 150
Time frame: Baseline, Day 150
Percentage Change in Apolipoprotein B (Apo B) From Baseline to Day 150
Time frame: Baseline, Day 150
Percentage Change in Apo B/Apo A-1 Ratio From Baseline to Day 150
Time frame: Baseline, Day 150
Change in Lipoprotein (a) [Lp(a)] From Baseline to Day 150
Time frame: Baseline, Day 150
Incidence of Treatment Emergent Adverse Events (TEAE) and Serious Adverse Events (SAE)
Time frame: From first dose of study treatment on Day 1 up to Day 180
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40392667Taub PR, Gutierrez A, Wewers D, Garcia Cantu E, Cao H, Deck C, Lesogor A, Ott D, Mena-Madrazo J, Zang X, Wright RS. Safety and Lipid-Lowering Efficacy of Inclisiran Monotherapy in Patients Without ASCVD: The VICTORION-Mono Randomized Clinical Trial. J Am Coll Cardiol. 2025 Jul 22;86(3):196-208. doi: 10.1016/j.jacc.2025.04.049. Epub 2025 May 5.
- A Plain Language Trial Summary is available on www.novctrd.comLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
42 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Inclisiran and Ezetimibe in people with Hypercholesterolemia, run by Novartis Pharmaceuticals at 42 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 sites in United States, Germany, Mexico, Colombia, Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 150 (time frame: Baseline, Day 150). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05763875, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2025.